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NCT Number: NCT05935683

Rhinosinusitis Italian Network: the Italian Registry for Severe, Uncontrolled Chronic Rhinosinusitis

This observatory aims to collect, as widely as possible, the Italian cases of patients with uncontrolled CRS. Patient will be enrolled by the centers of the Italian Network of Rhinosinusitis (Rhinosinusitis Italian Network: RINET), and they will be treated using a multidisciplinary team approach (allergists, otolaryngologists and pneumologists) in a real-world clinical set-up.

This real-life chronic rhinosinusitis registry aims at longitudinal data collection from patients attending specialist care centres across Italy.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital

Rozzano, MIlan, 20089, Italy

Location status: Recruiting

Location contact

Concetta Sirena, Dr.

CONTACT

[email protected]

342 0790871 ext. +39

Enrico Marco Heffler, MD, PhD

CONTACT

[email protected]

02 82241 ext. +39

About this study

The primary objectives of the study are:

  • to characterize and to describe the evolution of uncontrolled Chronic Rhinosinusitis (CRS);
  • to facilitate and to characterize the phenotyping and endotyping of CRS;
  • studying the efficacy and safety of the principal therapeutic strategies and approaches to uncontrolled CRS in real-life;
  • supporting the development of diagnostic methodologies and innovative therapeutic strategies for CRS;
  • to evaluate the clinical and economic-health impact of the different therapeutic approaches (including systemic corticosteroids) used for uncontrolled CRS;
  • to describe factors associated with therapeutic choices and how much this factors influence natural history of the CRS;
  • Studying and identifying biomarkers and predictors of response to different therapies;
  • to increase the "awareness" of CRS in patients, in public opinion, in the national and international scientific community, and in the Italian clinical community of the otolaryngologists, the allergists and the pneumologists.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with a confirmed diagnosis of bilateral Chronic Rhinosinusitis that have at least three (in case of patients previously treated with surgical approaches) or four (in case of patients never treated with nasal sinus surgery) of the following criteria:
  • Evidence of type 2 inflammation (at least 250 blood eosinophils per microliter and / or at least 10 eosinophils / HPF from a histological sample of sinus mucosa and / or at least one finding of moderate eosinophilia on nasal cytology and / or total serum IgE >100 IU / ml);
  • at least two Short courses of systemic corticosteroids or lorg-term Systemic Corticosteroids therapy for Chronic Rhinosinusitis;
  • Significant deterioration in the quality of life (Sinonasal Outcome Test 22 - SNOT-22>= 40 and / or Visual Analogue Scale - Global VAS of symptoms>= 5);
  • Loss of Smell (VAS for hyposmia> = 7)

Exclusion criteria

-

Treatment and study plan

Severe Uncontrolled Chronic Rhinosinusitis patients (CRS)

Other

Obsertvation

Other names: Adult chronic rhinosinusitis patients.

Primary outcomes

  1. Nasal Polyp Score

    Time frame: Every year to ten year

    Change from baseline in total Nasal Polyp Score at year 1 to ten. The Nasal Polyp Score is the sum of the right and left nostril scores (maximum 8), as evaluated by nasal endoscopy.

Study contacts

Contact information is provided by the study sponsor or research team.

Concetta Sirena, Dr.

CONTACT

[email protected]

342 0790871 ext. +39

Enrico Marco Heffler, MD, PhD

CONTACT

[email protected]

02 82241 ext. +39

Sponsors and collaborators

Lead sponsor

Italian Academy of Rhinology

Other

Collaborators

  • Accademia Italiana di Citologia Nasale

Registry information

Official study title

Rhinosinusitis Italian Network (RINET): the Italian Registry for Severe, Uncontrolled Chronic Rhinosinusitis

Acronym: RINET

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
Jul 7, 2023
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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